HOLTER 2000
Electrocardiograph, Ambulatory, With Analysis Algorithm
ZYMED MEDICAL INSTRUMENTATION
The following data is part of a premarket notification filed by Zymed Medical Instrumentation with the FDA for Holter 2000.
Pre-market Notification Details
| Device ID | K990170 |
| 510k Number | K990170 |
| Device Name: | HOLTER 2000 |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Contact | Gretel Lumley |
| Correspondent | Gretel Lumley ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-04-13 |
| Summary: | summary |
Trademark Results [HOLTER 2000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HOLTER 2000 75620199 not registered Dead/Abandoned |
Zymed Medical Instrumentation, Inc. 1999-01-13 |
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